Company · GB

Oxehealth Limited

FDA 510(k) clearances and medical device recalls filed under this name, 2021 to 2026. Name variants (Inc, Corp, punctuation) are merged.

6510(k) clearances (1 in 12 months)

0recalls (0 in 12 months)

0recalls that name a 510(k)

Product codes

Code	Device	Records
QME	Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate	5
LEL	Device, Sleep Assessment	1

Decided	510(k)	Device and applicant	Code
Feb 2, 2026	K251200	Vital Signs Oxehealth Limited, GB	QME
Aug 27, 2025	K243687	Vital Signs Oxehealth Limited, GB	QME
Apr 3, 2024	K233618	Oxevision Sleep Device Oxehealth Limited, GB	LEL
Apr 29, 2022	K220899	Oxehealth Vital Signs Oxehealth Limited, GB	QME
Jul 20, 2021	K211906	Vital Signs Oxehealth Limited, GB	QME
Mar 26, 2021	DEN200019	Oxehealth Vital Signs Oxehealth Limited, GB	QME

Date	Firm and product	Code	Linked 510(k)
No recalls in this window.